EMA plots end to adapted pathways assessment pilot
It should publish an interim report on the pilot between January–March 2016
A European Union (EU) pilot study should be completed next year developing so-called ‘adapted pathways’ assessments for medicines involving tests on human patients before standard clinical trials. But the European Medicines Agency (EMA) is still looking for companies wanting to participate. It should publish an interim report on the pilot next January–March and draft a final report by December 2016, once six products have undergone parallel scientific advice from EMA and health-technology-assessment bodies.
Adapted pathways systems are to be used for much-needed treatments where it is difficult to collect data using traditional routes and where large clinical trials could use many patients unlikely to benefit from the medicine. It involves the use of scientific advice; compassionate use; conditional approvals for medicines addressing life-threatening conditions; developing patient registries and other pharmacovigilance tools; collecting real-life data; and developing a risk-management plan for each medicine. Scientific advice given on individual medicines remains confidential at such early stages of product development.